
Historical and Ethical Foundations of GCP
Trace the evolution of research ethics from the Nuremberg Code through the Declaration of Helsinki and Belmont Report to understand why GCP protections exist.
Why does GCP exist?
Every regulation has a story. And the story behind Good Clinical Practice is not a comfortable one.
The requirements that govern clinical research today, the informed consent processes, the ethics committee reviews, the safety monitoring, none of these emerged from abstract philosophical debate. They were written in response to real events. Events in which researchers violated the trust of participants. Events in which science was used to justify cruelty. Events in which vulnerable populations were exploited in the name of knowledge.